Details for New Drug Application (NDA): 218947
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NDA 218947 describes CEPHALEXIN, which is a drug marketed by Alkem Labs Ltd, Anda Repository, Apothecon, Aurobindo Pharma, Barr, Belcher Pharms, Chartwell Rx, Facta Farma, Hikma, Ivax Sub Teva Pharms, Lupin, Purepac Pharm, Stevens J, Sun Pharm Inds (in), Sun Pharm Inds Ltd, Teva, Yoshitomi, Hikma Pharms, Vitarine, Yung Shin Pharm, and Aurobindo Pharma Ltd, and is included in fifty-two NDAs. It is available from thirty-eight suppliers. Additional details are available on the CEPHALEXIN profile page.
The generic ingredient in CEPHALEXIN is cephalexin. There are twenty-nine drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the cephalexin profile page.
The generic ingredient in CEPHALEXIN is cephalexin. There are twenty-nine drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the cephalexin profile page.
Summary for 218947
| Tradename: | CEPHALEXIN |
| Applicant: | Alkem Labs Ltd |
| Ingredient: | cephalexin |
| Patents: | 0 |
Suppliers and Packaging for NDA: 218947
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEPHALEXIN | cephalexin | TABLET;ORAL | 218947 | ANDA | Ascend Laboratories, LLC | 67877-891 | 67877-891-01 | 100 TABLET in 1 BOTTLE (67877-891-01) |
| CEPHALEXIN | cephalexin | TABLET;ORAL | 218947 | ANDA | Ascend Laboratories, LLC | 67877-892 | 67877-892-01 | 100 TABLET in 1 BOTTLE (67877-892-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 250MG BASE | ||||
| Approval Date: | Sep 27, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 500MG BASE | ||||
| Approval Date: | Sep 27, 2024 | TE: | AB | RLD: | No | ||||
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